Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a device that controls temperature based on sensors and firmware, with no mention of AI or ML algorithms for decision-making or data analysis.

Therapeutic

No.
The device warms fluids prior to administration to help prevent hypothermia, which is a supportive rather than a therapeutic function.

Diagnostic

No
The device is a fluid warmer, intended to warm blood products and intravenous fluids, not to diagnose medical conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly lists hardware components (Disposable Unit, Base Unit with electronics, Connecting Cable) in addition to firmware (SW).

IVD (In Vitro Diagnostic)

Based on the provided information, the QiF Blood and Fluid Warmer device is not an In Vitro Diagnostic (IVD).

Here's why:

Intended Use: The device's intended use is to warm blood, blood products, and intravenous fluids prior to administration to a patient. This is a therapeutic or supportive function, not a diagnostic one.
Device Description: The description details a system for heating fluids outside the body and delivering them to the patient. It does not involve analyzing biological samples to provide diagnostic information.
Lack of Diagnostic Function: There is no mention of the device being used to test, examine, or analyze specimens (like blood, urine, or tissue) to diagnose a disease or condition.

IVDs are devices used to perform tests on specimens taken from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The QiF Blood and Fluid Warmer does not fit this definition.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The QiF Blood and Fluid Warmer device is intended for warming blood, blood products, and intravenous fluids prior to administration. It is intended to be used by healthcare professionals in hospitals, clinics and field environments, to help prevent hypothermia.

Product codes (comma separated list FDA assigned to the subject device)

LGZ, BSB

Device Description

The Quality in Flow QiF Blood and Fluid Warmer is a portable sterile Fluid Path, in-line Blood and Fluid Warmer.

The QiF device is composed of the following main components:

1. Disposable Unit (DU) The disposable cartridge is made of a plastic oval box encasing a spiral Stainless Steel (SS) heat exchanger tube. The DU is located between the fluid container (intravenous solution or blood product) and the treated patient, outside of the patient body. The DU has a standard intravenous tube extension. The DU comprises the temperature sensors.
1. Base Unit (BU) The BU controls the performance of the system and the outflow fluid temperature. The power source is a rechargeable detachable battery located within the BU: the BU contains firmware (SW) and electronics (HW).
1. Connecting Cable (CC) a cable consisting of data and power wires connects between the BU and the DU to facilitate the transfer of data and electrical current.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

healthcare professionals in hospitals, clinics and field environments

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance tests were performed in order to demonstrate that the device has equivalent performance to its predicate. Specifically, testing was conducted to verify that the QiF device will warm plasma to the device set point temperature (38 ± 2 °C; 98.6±3.6°F).

In all instances, the device functioned as intended and demonstrated equivalent performance. Studies have not been performed to evaluate the effects on clotting factors in plasma products following warming with the QiF Blood and Fluid Warmer.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K163708

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 880.5725 Infusion pump.

(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).

Summary

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510(k) SUMMARY - K171215 Quality in Flow's QiF Blood and Fluid Warmer

Manufacturer: Quality in Flow Ltd.

Phone: (972) (54) 6600146 Contact Person: Neta Sherman

Date Prepared: September 26, 2017

Subject Device

Name of Device- QiF Blood and Fluid Warmer Common Name- QiF Blood and Fluid Warmer Regulation Number- 21 C.F.R 880.5725 Regulation Name- Infusion pump Regulatory class- class II Product Code LGZ, BSB Classification Panel- General Hospital

Predicate Device

510(k) Number- K163708 Name of Device- QiF Blood and Fluid Warmer Common Name- QiF Blood and Fluid Warmer Regulation Number- 21 C.F.R 880.5725 Requlation Name- Infusion pump Regulatory class- class II Product Code LGZ, BSB Classification Panel- General Hospital

Indications for Use

The QiF Blood and Fluid Warmer device is intended for warming blood, blood products, and intravenous fluids prior to administration. It is intended to be used by healthcare professionals in hospitals, clinics and field environments, to help prevent hypothermia.

Description

The Quality in Flow QiF Blood and Fluid Warmer is a portable sterile Fluid Path, in-line Blood and Fluid Warmer.

The QiF device is composed of the following main components:

1. Disposable Unit (DU) The disposable cartridge is made of a plastic oval box encasing a spiral Stainless Steel (SS) heat exchanger tube. The DU is located between the fluid container (intravenous solution or blood product) and the treated patient, outside of the

1

patient body. The DU has a standard intravenous tube extension. The DU comprises the temperature sensors.

1. Base Unit (BU) The BU controls the performance of the system and the outflow fluid temperature. The power source is a rechargeable detachable battery located within the BU: the BU contains firmware (SW) and electronics (HW).
1. Connecting Cable (CC) a cable consisting of data and power wires connects between the BU and the DU to facilitate the transfer of data and electrical current.

Purpose of 510(k)

The purpose of this 510(k) is to replace the contraindication against plasma warming with the QiF device with a precaution statement.

Performance Data

Performance tests were performed in order to demonstrate that the device has equivalent performance to its predicate. Specifically, testing was conducted to verify that the QiF device will warm plasma to the device set point temperature (38 ± 2 °C; 98.6±3.6°F).

In all instances, the device functioned as intended and demonstrated equivalent performance. Studies have not been performed to evaluate the effects on clotting factors in plasma products following warming with the QiF Blood and Fluid Warmer.

Technological Characteristics

The QiF Blood and Fluid is not changed, thus it has identical technological characteristics as the predicate QiF Blood and Fluid Warmer.

The QiF Blood and Fluid Warmer is a portable, inline Blood and Fluid Warmer located between the fluid container (intravenous solution or blood product) and the treated patient, outside of the patient body. The device is comprised of a Base Unit (BU) and a sterile disposable cartridge (Disposable Unit). The Disposable Unit is composed of a plastic oval box encasing a spiral stainless steel heat exchanger tube. The Base Unit contains Firmware (software) and electronics (HW). The Base Unit controls the performance of the system and the fluid outflow temperature. The power source is a rechargeable detachable battery located within the Base Unit. The DU has a standard intravenous tube extension.

Substantial Equivalence

An SE Table is presented below:

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| | Quality in Flow – QiF
Blood and Fluid Warmer
model 01 [Subject] | Quality in Flow – QiF
Blood and Fluid Warmer
model 01 [K163708] | SE Justification |
|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| Indications for Use | Intended for warming
blood, blood products, and
intravenous fluids prior to
administration. It is
intended to be used by
healthcare professionals in
hospitals, clinics and field
environments, to help
prevent hypothermia. | Intended for warming
blood, blood products, and
intravenous fluids prior to
administration. It is
intended to be used by
healthcare professionals in
hospital, clinics and field
environments, to help
prevent hypothermia. | Same |
| Intended use | Medical emergencies or
surgeries where warm fluid
administration is required
to treat the patient.

Whenever parenteral
introduction of
normothermic fluid are
desired or indicated | Medical emergencies or
surgeries where warm fluid
administration is required
to treat the patient.

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Conclusions

The QiF Blood and Fluid Warmer is substantially equivalent to the predicate device.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 27, 2017

Quality In Flow Ltd. % John Smith Partner Hogan Lovells US LLP 555 Thirteenth St. NW Washington, District of Columbia 20004

Re: K171215

Trade/Device Name: QiF Blood and Fluid Warmer Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: LGZ, BSB Dated: April 25, 2017 Received: April 25, 2017

Dear John Smith:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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